National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood

• Conditions: Early Detection of Cancer

• Registration Number: NCT03183401
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

The DENACAPST programme represents an important initiative to provide near nation-wide roll-out of an important cancer surveillance program for childhood cancer survivors. The program is based on internationally recognized standards in cancer surveillance, which were developed by the International Guideline Harmonization Group (IGHG) with support of all relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and the United States and recognized French recommendations about breast screening for women at high risk of cancer.

With this programme, French centers organized themselves to provide to childhood cancer survivors adequate medical attention, which includes close medical surveillance for breast/thyroid cancer where appropriate, based on adequate risk stratification.

The aim of the study is to analyze if the recommendations about breast and thyroid cancer screening are followed in this population and secondly to provide more informations about these second cancers and about the screening.

Detailed Description

Every center which has patient at risk can participate. Main inclusion criteria : French childhood cancer survivor (5 years or more of delay with the treatment) - becoming adult - with a past history of radiotherapy at the age of 20 years or before, with a significant dose irradiation on the thyroid or the breast

The inclusion of patients are validated by one team

Thyroid screening programme is based on US each 2 years Breast screening programme is based mainly on MRI each year

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21
• Study Start: 2017-07-09
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• childhood cancer survivor, and

• treated with radiotherapy

• health status compatible, and

• have had a long-term follow-up consultation describing a personalized post-cancer plan and,

• informed consent signed by patient

  • Inclusion criteria for breast screening

• being a woman and being 25 years or more for breast cancer screening, with a minimum delay of 8 years after radiotherapy, or

• with a significant irradiation dose to the breast (Irradiation that delivered at least 10 Gy on at least part of the breast (v 5> 10 Gy) or on the mammary bud (v 100> 10 Gy) - (centrally validated dose) or received TBI (Total Body Irradiation)> 8 Gy according to a bi-fractioned scheme or> 6 Gy in single dose)

  +Inclusion criteria for thyroid screening:

• being a man or a woman and being 18 years or more for thyroid cancer screening with a minimum delay of 5 years after radiotherapy, and,

• with a significant irradiation dose to the thyroid (Irradiation having delivered at least 3 Gy on the thyroid (v100> 3 Gy), or having received a TBI (Total Body Irradiation)> 2 Gy, and / or treatment with 131i-metaiodobenzylguanidine), and

Exclusion Criteria

• life expectancy <10 years due to other pathology

• patient in regular follow-up within the framework of a genetic susceptibility (ex li fraumeni)

• person placed under safeguard of justice

  • exclusion criteria for breast cancer screening :

• patient treated with bilateral mastectomy, or

• patient being treated for breast cancer, or

• patient initially treated with radiotherapy for breast cancer

  • exclusion criteria for breast cancer screening :

• Thyroidectomy, or

• patient undergoing treatment or with a personal history of thyroid cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
follow of cancer screening recommendations	2 years	number of persons at risk found percentage of persons at risk contacted who answered percentage of persons contacted, who answered, who accepted the screening

Secondary Outcome Measures

Name	Time	Method
description of breast cancer screening	2 years	evaluation of the programme
psycho social analyze	2 years	evaluated by auto-questionaries :initial / final and comparison with persons who accepted to answer but who did not accept the screening
description of thyroid cancer screening	2 years	evaluation of the programme
description of second cancers	2 years	analyze of the histological data

Trial Locations

Locations (1)

Charlotte Demoor-Goldschmidt; 🇫🇷 Villejuif, France